Schwann Cell Therapy for Peripheral Nerve Injury

Overseen By George Jimsheleishvili, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: W. Dalton Dietrich

Disqualifiers: Pregnancy, HIV, Hepatitis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-transplantation

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Autologous Human Schwann Cells for peripheral nerve injury?

Research shows that Schwann cells, which support nerve repair, have been effective in animal studies for nerve regeneration. Additionally, studies on similar treatments using Schwann cells derived from bone marrow in monkeys have shown safety and effectiveness in nerve recovery, suggesting potential benefits for human nerve injuries. ^{1 2 3 4 5}

Is Schwann cell therapy safe for humans?

Research shows that autologous Schwann cell therapy has been generally safe in human trials for spinal cord injuries, with no serious adverse effects reported. Some patients experienced temporary sensations or muscle spasms, but there were no signs of infection or further neurological issues. ^{6 7 8 9 10}

How is Schwann Cell Therapy for Peripheral Nerve Injury different from other treatments?

Schwann Cell Therapy is unique because it uses the patient's own Schwann cells, which are supportive cells in the nervous system, to aid in nerve repair and regeneration. This approach is different from other treatments as it involves the use of autologous cells (cells from the same individual), potentially reducing the risk of immune rejection and enhancing the body's natural healing process. ^{1 3 6 11 12}

Research Team

Allan Levi, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults aged 18-65 who have had a severe peripheral nerve injury with a gap of 5-10 cm between healthy nerve endings within the last year. It's not suitable for those unable to undergo an MRI, with conditions affecting sural nerve harvest, gaps over 10 cm, local cancer history, pregnant women, or those with certain diseases or substance abuse.

Inclusion Criteria

I have a nerve injury with a gap of 5 to 10 cm between ends.

I have had a severe nerve injury in my arm or leg within the last year.

I have had a severe nerve injury in my arm or leg within the last year.

Exclusion Criteria

I do not have any health conditions that could affect my safety or participation in the study.

You have a severe injury to the nerves in your arms or legs that is longer than 10 centimeters.

I have had cancer or radiation in the area where I now have nerve damage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous human Schwann cells harvested from their own sural nerve for nerve autograft repair

Immediate post-transplantation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, sensory recovery, and nerve-graft continuity

5 years

Long-term safety monitoring

Participants are monitored for adverse events, tumorigenesis, and unexpected changes in nerve structure

2 years

Treatment Details

Interventions

• Autologous Human Schwann Cells

Trial Overview The study tests whether using one's own Schwann cells (ahSC) to repair damaged nerves can improve healing and function. Participants will receive ahSCs during surgery where their own nerves are used as grafts in areas like the sciatic nerve or brachial plexus.

Participant Groups

Group I: Autologous human Schwann cells Experimental Treatment 1 Intervention

All participants will receive autologous human Schwann cells harvested from their own sural nerve.

Who Is Running the Clinical Trial?

W. Dalton Dietrich

Lead Sponsor

Trials

7

Recruited

60+

The Miami Project to Cure Paralysis

Collaborator

Trials

6

Recruited

40+

Findings from Research

The study developed a rapid protocol for creating pure cultures of genetically modified adult human Schwann cells, which are crucial for repairing peripheral nerves.

Using an optimized electroporation method, nearly half (48.4%) of the Schwann cells were successfully transfected to produce proteins that promote nerve regeneration, indicating a promising approach for enhancing nerve repair strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous adult human Schwann cells genetically modified to provide alternative cellular transplants in peripheral nerve regeneration. Haastert, K., Mauritz, C., Matthies, C., et al.[2006]

Autologous adult human Schwann cells (SCs) show promise for spinal cord injury repair, with research over the past 40 years establishing their potential for clinical trials.

Studies in rat models have demonstrated that transplanted SCs can promote spinal cord repair, and preparations are underway for FDA-approved clinical trials to test this therapy in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From transplanting Schwann cells in experimental rat spinal cord injury to their transplantation into human injured spinal cord in clinical trials. Bunge, MB., Monje, PV., Khan, A., et al.[2018]

A Phase I clinical trial involving six paraplegic participants demonstrated that transplanting autologous human Schwann cells into the spinal cord injury site is safe, with no surgical or neurological complications observed one year post-transplantation.

The study confirmed the feasibility of harvesting Schwann cells from a peripheral nerve and transplanting them within 4-7 weeks of injury, indicating a potential therapeutic approach for enhancing recovery after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. Anderson, KD., Guest, JD., Dietrich, WD., et al.[2022]

A 1-year follow-up study of four patients with chronic spinal cord injury treated with autologous Schwann cell transplantation showed no adverse effects, indicating that the procedure is generally safe.

Only one patient experienced motor and sensory improvement after the transplantation, suggesting that while Schwann cell transplantation is safe, its efficacy in promoting recovery from spinal cord injury remains uncertain and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic thoracic spinal cord injury patients with autologous Schwann cell transplantation: an interim report on safety considerations and possible outcomes. Saberi, H., Moshayedi, P., Aghayan, HR., et al.[2008]

Using human autologous serum instead of fetal bovine serum for cultivating human schwann cells significantly enhances the safety of clinical cell transplantation procedures, as demonstrated in a study involving 10 sural nerves from brain death donors.

The study achieved a high cell purity of 97% to 99% (mean 98.11%) without the use of growth factors, indicating that clinical-grade schwann cell cultivation is feasible and can meet safety standards for future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical grade cultivation of human Schwann cell, by the using of human autologous serum instead of fetal bovine serum and without growth factors. Aghayan, HR., Arjmand, B., Norouzi-Javidan, A., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Autologous adult human Schwann cells genetically modified to provide alternative cellular transplants in peripheral nerve regeneration. [2006]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic review of the therapeutic use of Schwann cells in the repair of peripheral nerve injuries: Advancements from animal studies to clinical trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Use and Delivery of Stem Cells in Nerve Regeneration: Preclinical Evidence and Regulatory Considerations. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

From transplanting Schwann cells in experimental rat spinal cord injury to their transplantation into human injured spinal cord in clinical trials. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term observation of auto-cell transplantation in non-human primate reveals safety and efficiency of bone marrow stromal cell-derived Schwann cells in peripheral nerve regeneration. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Schwann Cell Precursors from Human Pluripotent Stem Cells as a Potential Therapeutic Target for Myelin Repair. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Treatment of chronic thoracic spinal cord injury patients with autologous Schwann cell transplantation: an interim report on safety considerations and possible outcomes. [2008]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical grade cultivation of human Schwann cell, by the using of human autologous serum instead of fetal bovine serum and without growth factors. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Scalable culture techniques to generate large numbers of purified human Schwann cells for clinical trials in human spinal cord and peripheral nerve injuries. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The properties of human Schwann cells: Lessons from in vitro culture and transplantation studies. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Schwann Cell Cultures: Biology, Technology and Therapeutics. [2021]